BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP

    MDR report key: 7075041 · Received December 1, 2017

    Report

    Report Number
    1917413-2017-00198
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    April 4, 2016
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    KDT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH THE 510K NUMBER LISTED AS K790366. IT IS CORRECTED TO READ EXEMPT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT #: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: BD RECEIVED NEARLY 200 SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMERS' INDICATED FAILURE MODE FOR MOLD/FOREIGN MATTER WAS NOT OBSERVED. BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. CONCLUSION: UNCONFIRMED COMPLAINT. WITHOUT A LOT NUMBER, AS WELL AS UNCONFIRMED FAILURE MODE ON RETURNED SAMPLES, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS¿ INDICATED FAILURE MODE OF FOREIGN MATTER/MOLD ON URINE CUPS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME 120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUPS HAD A MOLDY APPEARANCE, A FOREIGN MATTER CONTAMINATION ISSUE. NO SERIOUS INJURY, BLOOD TO MUCOUS MEMBRANE EXPOSURE OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853781 120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP URINE STORAGE CUP KDT BECTON, DICKINSON & CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other